Dry Age Related Macular Degeneration, Epiretinal Membrane, Intraretinal Hyporeflective Space, IS/OS (Ellipsoid Zone) Disruption, Macular Abnormalities, Retina Disease, Retinal Pigment Epithelium (RPE) Atrophy, Retinal Pigment Epithelium (RPE) Elevation, Subretinal Hyporeflective Space, Vitreoretinal Abnormality
Conditions
Brief summary
This study will measure how well PathFinder 1.0 detects retinal abnormalities on macular cube OCT B-scans by assessing its sensitivity and specificity.
Interventions
DEVICEPathFinder 1.0 on CIRRUS HD-OCT
Participants undergo standard OCT imaging on CIRRUS HD-OCT systems, and the investigational PathFinder software analyzes the images for macular abnormalities without influencing clinical care.
Sponsors
Carl Zeiss Meditec-Dublin CoCe
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Able and willing to make the required study visits. 2. Able and willing to give written informed consent and follow study instructions. 3. Able and willing to complete ophthalmic imaging. 4. Adults 18 years of age or older. The subject population will be comprised of two groups (all categories below pertain to the central 6x6 mm macula area): Group A 1\. Subjects with absence of macular abnormalities Group B 1. Subjects with Disruption of the vitreoretinal interface (VRI) 2. Subjects with Intraretinal hyporeflective space (IRHS) 3. Subjects with Subretinal hyporeflective space (SRHS) 4. Subjects with IS/OS (Ellipsoid Zone) disruption 5. Subjects with Retinal Pigment Epithelium (RPE) elevation 6. Subjects with Retinal Pigment Epithelium (RPE) atrophy 7. Other abnormalities
Exclusion criteria
1. Inability to undergo the required tests. 2. Unable to give consent or follow study instructions. 3. Inability to fixate that precludes obtaining acceptable macula scans in the study eye. 4. Visudyne (verteporfin) injection within the last 48 hours in the study eye. 5. Pilocarpine or Vuity use within the last 24 hours in the study eye. 6. Dense media opacity precluding adequate visualization of the retina in the study eye. 7. Vitreous floaters that preclude obtaining acceptable scans in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of PathFinder 1.0 | Baseline (single study visit OCT acquisition) | Sensitivity is the proportion of scans that PathFinder 1.0 correctly identifies as having any macular abnormality. |
| Specificity of PathFinder 1.0 | Baseline (single study visit OCT acquisition) | Specificity is the proportion of scans that PathFinder 1.0 correctly identifies as having no macular abnormality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity by clinical diagnosis | Baseline | Sensitivity and specificity of PathFinder 1.0, calculated separately within each PI-recorded diagnosis group. |
| Sensitivity by macular abnormality type | Baseline | Sensitivity of PathFinder 1.0 calculated separately for each OCT lesion type. |
| Positive Predictive Value and Negative Predictive Value | Baseline | Positive Predictive Value is the proportion of B-scans called abnormal by PathFinder 1.0. |
| Rate of acceptable versus unacceptable B-scans | Baseline | Proportion of B-scans within each macular cube, and overall, that is marked as "acceptable" or "unacceptable". |
| Algorithm repeatability (precision) | Baseline | Repeatability of PathFinder 1.0 results, expressed as the consistency of the proportion of abnormal B-scans per macular cube across repeated scans. |
Countries
United States
Contacts
CONTACTPatricia Sha, Optometrist
Outcome results
None listed